Acupuncture for Pain Management During Uterine Aspiration

NCT03391986 | Completed Results DMC FDA Device

• 1 other identifier: AAAR2610
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will be a randomized, double blinded, placebo-controlled trial to evaluate the efficacy of auricular acupuncture as adjunct for pain management during abortion. Women seeking first trimester uterine aspiration procedure who enroll in the study will be randomized to receive: 1) auricular acupuncture using pyonex needles, 2) placebo using an adhesive, 3) or routine care. Both participants and the treating physician will be unaware of treatment assignment. The primary outcome will compare the maximum pain score as measured by the visual analog scale (VAS) between the auricular acupuncture group and the routine care group. The secondary outcome will compare the maximum pain score between placebo group to the routine care group. The study will also investigate patient satisfaction.

Conditions

Pain Acute; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care

  Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales.

  at the completion of the procedure (approximately 10 minutes later)

Secondary Outcomes (2)

• Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care

  prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later)

• Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care

  at the completion of the procedure (approximately 5-10 minutes)

Study Arms (3)

Pyonex needles

ACTIVE COMPARATOR

This arm will receive modified battlefield auricular acupuncture using SEIRIN® Pyonex™ Acupuncture Needles.

Device: SEIRIN® Pyonex™ Acupuncture Needles

Placebo adhesives

PLACEBO COMPARATOR

This arm will receive placement of adhesives using the modified battlefield auricular acupuncture placement points using 12 mm Plasters.

Procedure: 12 mm Plasters

Routine Care

NO INTERVENTION

This arm will receive no intervention.

Interventions

SEIRIN® Pyonex™ Acupuncture Needles DEVICE

Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix

Also known as: Needle, Acupuncture, Single Use

Pyonex needles

12 mm Plasters PROCEDURE

12 mm (0.5"). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix

Also known as: hypoallergenic, adhesive replacement plasters

Placebo adhesives

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English- or Spanish-speaking women
• Age 18 or older
• Seeking first trimester suction aspiration for undesired pregnancy, early pregnancy failure, retained products of conception, or molar pregnancy
• Intrauterine pregnancy with gestational age less than or equal to 12 weeks and 6 days
• Willingness to receive acupuncture and be randomized in the study

You may not qualify if:

• Allergy to adhesives
• Allergy to or cannot receive ibuprofen or 1% lidocaine
• Congenital anomalies of the ear including anotia and microtia

Sponsors & Collaborators

• Columbia University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (45)

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Related Links

• Guttmacher Institute. 2016. Induced Abortion in the United States

MeSH Terms

Conditions

Acute Pain

Interventions

Needles; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Carolyn Westhoff, MD
• Organization: Columbia University

clw3@columbia.edu

212-305-4805

Study Officials

• Carolyn Westhoff, MD MSc

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant: only participants in the pyonex needle and placebo adhesive group will be masked during the study. Equipment is opened behind the participant and the needles and adhesives are placed outside the view of the participant. Care Provider: A colored hat that covers the participants ears will be placed. Outcomes Assessor: Group assignment will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Population and Family Health

Model Details: Participants will be randomized to either 1 - auricular acupuncture with pyonex needle, 2 - placebo adhesive, or 3 - routine care using a 1:1:1 ratio. The randomization scheme will use randomly permuted blocks with a block size of 6 or 9.

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: January 5, 2018
• Study Start: September 9, 2017
• Primary Completion: April 30, 2018
• Study Completion: July 1, 2018
• Last Updated: September 3, 2019
• Results First Posted: September 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)